Panels › Gastroenterology, Urology › Product code FLD · Class 2
Apparatus, Hemoperfusion, Sorbent
Regulation 876.5870
0510(k)s in 12 months (11 all time)
0recalls in 12 months (7 all time)
1recalls that name a 510(k)
Top companies in FLD
| Company | 510(k)s | Recalls |
|---|---|---|
| Gambro Renal Products | 3 | 2 |
| Clark Research and Development Inc | 0 | 4 |
| Hemocleanse, Inc. | 3 | 0 |
| Extracorporeal Medical Specialities, Inc. | 2 | 0 |
| American Health Care Systems, Inc. | 1 | 0 |
| Asahi Medical Co., Ltd. | 1 | 0 |
| Baxter Healthcare Corporation | 0 | 1 |
| Gambro, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 21, 2017 | Baxter Healthcare Corporation MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541 Terminated |
FLD | K133807 |
| Aug 13, 2014 | Gambro Renal Products, Incorporated X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 Terminated |
FLD | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch Terminated |
FLD | None listed |
| Feb 28, 2007 | Clark Research and Development Inc Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437 Terminated |
FLD | None listed |
| Feb 28, 2007 | Clark Research and Development Inc Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 175 mL, Clark Research and Development, Inc. Folsom, LA 70437 Terminated |
FLD | None listed |
| Feb 28, 2007 | Clark Research and Development Inc Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 100mL, Clark Research and Development, Inc. Folsom, LA 70437 Terminated |
FLD | None listed |
| Feb 28, 2007 | Clark Research and Development Inc Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 50mL, Clark Research and Development, Inc. Folsom, LA 70437 Terminated |
FLD | None listed |
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